Hazardous drugs table

Hazardous drug: a drug that exhibits one or more of the following six characteristics in humans and/or animals^r:

1. carcinogenicity, or the ability to cause cancer; a carcinogen
2. genotoxicity, or the ability to cause a change or mutation in genetic material; a mutagen
3. teratogenicity or other developmental toxicity, or the ability to cause foetal malformation or defects in foetal development; a teratogen
4. reproductive toxicity or fertility impairment
5. serious organ toxicity or adverse health effects at low doses
6. the structure and toxicity profiles of new drugs that mimic existing drugs determined hazardous by the five previous criteria

Anti-cancer (antineoplastic): an agent used to control or kill cancer cells; includes cytotoxic, hormonal, immune-system-modifying (immunomodifier), some antiviral, biological and molecular targeted therapies.

Biohazard: an infectious agent or hazardous biological material that presents a risk to the health of humans or the environment.

Carcinogenicity: ability or tendency to induce cancer.

Cytotoxic: an agent capable of disrupting the growth and function of both healthy and diseased cells and can be carcinogenic, genotoxic, mutagenic, teratogenic or hazardous to cells in any way. Commonly used in referring to anti-cancer drugs that selectively damage or destroy dividing cells.

Developmental toxicity: toxicity resulting in adverse effects induced during pregnancy, or as a result of parenteral exposure, that can be manifested at any point in the life span of the organism.

Genotoxicity: toxicity resulting in heritable (passed on to progeny/offspring) changes in the genetic material in germ cells, namely spermatocytes or oocytes via chemical interaction with DNA and/or non-DNA targets. Genotoxins include substances that are mutagenic; substances that induce transmissible changes in DNA structure involving a single gene or a group of genes.

Immunomodifier: an agent that interacts in some way with the immune system either to stimulate it to recognise and attack cancer cells or to inhibit the production of abnormal immune system cells or molecules present as a result of cancer.

Reproductive toxicity: any effect of agents that would interfere with reproductive ability or capacity (fertility), including effects on lactation.

Targeted therapies: agents that block the growth and spread of cancer by interfering with specific molecules involved in tumour growth and progression.

Teratogenicity: ability to disturb the development of an embryo or foetus. Teratogens can halt a pregnancy or produce a congenital malformation (birth defect).

These tables are based on the NIOSH^r, IARC^r and product information recommendations and only include drugs used in the treatment of cancer. They are intended as a guide and should not be construed as complete representation of all hazardous drugs used in health care settings.

Some drugs defined as hazardous may not pose a significant risk of direct occupational exposure because of their dosage formulation (e.g. intact medications such as coated tablets or capsules that are administered to patients without modifying the formulation). However, they may pose a risk if solid drug formulations are altered outside a ventilated cabinet (e.g. If tablets are crushed or dissolved, or if capsules are pierced or opened). The dust from uncoated tablets may present a risk of exposure by skin contact and/or inhalation when the tablets are counted.^r

Reproductive hazardous drugs have a potential to be an occupational hazard to those healthcare workers (both male and female) who are actively trying to conceive and females who are pregnant, breastfeeding or may become pregnant. These healthcare workers should use precautions when handling these drugs.^r 

Occupational Health and Safety and Worker Compensation authorities^rr, as well as various professional practise standards^rr, uniformly mandate the use of personal protective equipment (PPE) by healthcare workers who handle hazardous drugs. While the tables below separate drugs into the categories ‘cytotoxic’ and ‘non-cytotoxic’ there is no intention to imply that hazardous drug handling recommendations should not be applied, including the use of PPE, in either case. Due to the existence of minimal data regarding occupational risk involved in administering many agents, eviQ recommends PPE be employed unless local institutional guidelines exist that specifically address occupational risk minimisation for individual agents.

The following tables list common drugs used in the treatment of cancer classified as hazardous, or developmental and/or reproductive hazardous.

Hazardous cytotoxic drugs

NIOSH recommends full PPE when handling and administering these drugs^r.

Note:

• Many of these drugs may also pose a developmental and/or reproductive risk for populations at risk.

Drug name	Drug name
Aflibercept	Idarubicin
Amsacrine	Ifosfamide
Azacitidine	Inotuzumab ozogamicin
Azathioprine	Irinotecan
Belantamab mafodotin	Ixazomib
Bendamustine	Lomustine
Bleomycin	Melphalan
Bortezomib	Mercaptopurine
Brentuximab vedotin	Methotrexate
Busulfan	Mitomycin
Cabazitaxel	Mitotane
Capecitabine	Mitozantrone
Carboplatin	Nab-paclitaxel
Carfilzomib	Oxaliplatin
Carmustine	Paclitaxel
Chlorambucil	Pemetrexed
Cisplatin	Pegaspargase
Cladribine	Polatuzumab vedotin
Clofarabine	Pralatrexate
Cyclophosphamide	Procarbazine
Cytarabine	Raltitrexed
Cytarabine liposomal	Romidepsin
Dacarbazine	Sacituzumab govitecan
Dactinomycin (actinomycin D)	Temozolomide
Daunorubicin	Teniposide
Docetaxel	Thiotepa
Doxorubicin	Tioguanine
Doxorubicin liposomal	Topotecan
Epirubicin	Trabectedin
Eribulin	Trastuzumab deruxtecan
Etoposide	Trastuzumab emtansine
Etoposide phosphate	Trifluridine/tipiracil
Fludarabine	Valganciclovir
Fluorouracil	Vinblastine
Fotemustine	Vincristine
Ganciclovir	Vindesine
Gemcitabine	Vinflunine
Gemtuzumab ozogamicin	Vinorelbine
Hydroxyurea	Vismodegib

Hazardous non-cytotoxic drugs

For parenteral and oral liquid formulations NIOSH recommends full PPE when handling and administering. Intact drugs (such as coated tablets or capsules) may not pose the same degree of occupational exposure risk as compounded injectable drugs due to their dosage formulation. For these intact formulations NIOSH recommends single gloving for handling and administration. However, if these formulations are manipulated (crushed, dissolved etc.) they may pose a higher risk and full PPE is recommended. Healthcare workers (both male and female) who are actively trying to conceive and females who are pregnant, breastfeeding or may become pregnant should use PPE when handling all formulations of these drugs.^r

Note:

• Some of these drugs may also pose a developmental and/or reproductive risk for populations at risk. 
• Drugs that only meet criteria as a developmental and/or reproductive hazard are identified in the table with a blue cell colour.

Drug name	Drug name
Abemaciclib	Letrozole
Abiraterone	Leuprorelin*^
Acalabrutinib	Lorlatinib
Afatinib	Medroxyprogesterone acetate
Alectinib	Megestrol
Alpelisib	Midostaurin
Anastrozole	Mycobacterium bovis (Bacillus Calmette and Guerin (BCG) strain)
Apalutamide	Mycophenolate* (acid and mofetil)
Arsenic trioxide*	Neratinib
Atezolizumab	Nilotinib
Avelumab	Niraparib
Axitinib	Nivolumab
Bicalutamide	Olaparib**
Binimetinib	Osimertinib
Blinatumomab	Palbociclib
Brigatinib	Pazopanib
Cabozantinib	Pembrolizumab
Cemiplimab	Plerixafor
Ceritinib	Pomalidomide
Ciclosporin*	Ponatinib
Cobimetinib	Regorafenib
Crizotinib	Ribociclib
Cyproterone	Ripretinib
Dabrafenib	Ruxolitinib
Darolutamide	Sotorasib
Dasatinib	Selinexor
Degarelix*	Sirolimus*
Encorafenib	Sonidegib
Entrectinib	Sorafenib
Enzalutamide	Sunitinib
Erlotinib	Tacrolimus*
Everolimus	Tamoxifen
Exemestane	Temsirolimus*
Flutamide	Tepotinib
Fulvestrant^	Thalidomide
Gefitinib	Trametinib
Gilteritinib	Tretinoin
Goserelin^	Triptorelin*^
Ibrutinib	Venetoclax
Idelalisib	Vandetanib
Imatinib	Vemurafenib
Lapatinib	Vorinostat
Lenalidomide	Zanubrutinib
Lenvatinib	-

* For parenteral and oral liquid formulations of these drugs NIOSH recommends PPE when handling and administering.

** Olaparib is not classified as cytotoxic however has cytotoxic inducing effects so is considered hazardous.^r 

^ NIOSH groups these agents in Group 1 i.e. recommending double gloving and a protective gown during administration. The risk of occupational exposure from prefilled syringes is difficult to quantify and no guidance provided in the literature. Whilst we have chosen to predominantly adopt the NIOSH 2016 definitions of hazardous medicines, we propose that for the administration of prefilled syringes, a more pragmatic approach may be taken permitting these agents to be administered, similarly to intact formulations.

Reproductive and/or developmental hazardous non-anti-cancer drugs

Healthcare workers (both male and female) who are actively trying to conceive and females who are pregnant, breastfeeding or may become pregnant should use full PPE when handling these drugs. Intact drugs (such as coated tablets or capsules or prefilled syringes) may not pose the same degree of occupational exposure risk as compounded injectable drugs due to their dosage formulation. For these intact formulations NIOSH recommends single gloving for handling and administration. However, if these formulations are manipulated (crushed, dissolved etc.) they may pose a higher risk and full PPE is recommended.^r All other healthcare workers handling these medications should use universal precautions.

Drug name	Drug name
Entecavir	Ribavirin
Fluconazole	Tenofovir
Lamivudine	Voriconazole
Pamidronate	Zoledronic acid
Pentamidine*	-

* For aerolised pentamidine a sensible approach would be to wear PPE and appropriate respiratory protection during administration.

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Version 8

Date

Summary of changes

28/11/2022

Cytotoxic drug table updated to include: belantamab mafodotin, cytarabine liposomal, gemtuzumab ozogamicin, mitotane, pegaspargase, sacituzumab govitecan and trastuzumab deruxtecan. Non-Cytotoxic drug table updated to include: apalutamide, cemiplimab, entrectinib, gilteritinib, nivolumab, ripretinib, selinexor, sotorasib, tepotinib and zanubrutinib. Asparaginase and nilutamide removed as no longer TGA registered. "Anti-cancer" removed from "Hazardous cytotoxic anti-cancer drugs" and "Hazardous non-cytotoxic anti-cancer drugs" tables titles. Note added to the preamble for both tables to say that the drugs in both tables may also pose a developmental and/or reproductive risk for populations at risk. "Reproductive hazardous drugs" table title changed to "Reproductive and/or developmental hazardous non anti-cancer drugs". Anti-cancer drugs in this table (alpelisib, darolutamide, lorlatinib, midostaurin, pembrolizumab, plerixafor, tretinoin and venetoclax) moved to hazardous non-cytotoxic drug table. Version increase to V.8.

Version 7

Date	Summary of changes
17/05/2020	Non-Cytotoxic drug table updated to include: acalabrutinib and brigatinib. Reproductive hazardous drugs table updated to inlcude: alpelisib, darolutamide, lorlatinib, midostaurin, pembrolizumab. Version increase to V.7

Version 6

Date	Summary of changes
20/04/2020	Cytotoxic drug table updated to include Inotuzumab ozogamicin and Polatuzumab vedotin. Venetoclax moved from Hazardous cytotoxic antineoplastics​ table to the Reproductive hazardous drugs table. Version increase to V.6

Version 5

Date

Summary of changes

25/11/2019

Cytotoxic drug table updated to include Ixazomib, Vindesine, Vinflunine , Vismodegib. Non- cytotoxic drug table updated to include Abemaciclib, Atezolizumab, Avelumab, Binimetinib, Blinatumomab, Durvalumab, Encorafenib, Neratinib, Niraparib , Sonidegib. Daratumumab not for inclusion. Removal of information pertaining to safe handling of monoclonal antibodies in the cancer setting from this document as it is included in ID 188 - Safe handling and waste management of hazardous drugs.  Footnote added re the pragmatic administration of prefilled syringe under Hazardous non-cytotoxic antineoplastics. Version increase to V.5

Version 4

Date	Summary of changes
11/01/2010	Approved for publishing on eviQ.
10/07/2011	New definitions incorporated.
15/04/2013	Internal review of document. Key changes: deleted hazard risk column and table divided into 3 sections hormonal drugs removed from table added eviQ recommendation of using PPE deleted link to IARC monographs and IARC classification groups of carcinogenic risk.
11/09/2013	Azacitidine added to cytotoxic table.
06/02/2015	Internal review of document. Key change: new drugs and hormonal drugs added to table as per NIOSH 2014 guidelines.
12/02/2013	Added Supporting Document to title.
30/11/2016	Drug table updated to include new drugs and Monoclonal Antibodies (MABs) removed from table (except conjugated MABs) as per NIOSH 2016 guidelines. New statement on the Safe Handling of MABs added.
30/03/2017	Hazardous drug table updated to include further guidance on safe handling of reproductive hazardous drugs. A number of 'nibs' added to the table.
31/05/2017	Transferred to new eviQ website. Version number increase to v.3.
25/10/2017	Carfilzomib was moved into the 'hazardous cytotoxic drugs' table from the 'hazardous non-cytotoxic drugs' table to align with published data.
04/07/2018	Pamidronate added to the reproductive hazardous drugs as per NIOSH 2017 guidelines.
19/02/2019	Drug class removed from all tables. Cytotoxic drug table updated to include: aflibercept, pralatrexate, trifluridine/tipiracil,  venetoclax Non- cytotoxic drug table updated to include: alectinib, cabozantinib, ceritinib, cobimetinib, cyproterone, medroxyprogesterone acetate, midostaurin, osimertinib, palbociclib, ribociclib, ruxolitinib Reproductive table updated to include tenofovir. Version number increase to v.4
16/07/2019	Bacillus Calmette-Guerin (BCG) drug name updated to Mycobacterium bovis (Bacillus Calmette and Guerin (BCG) strain) to align with product information.